Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

US FDA Changing View Of Citizen Petition Response Time, Could Eliminate Serial Refiling

Executive Summary

By aligning petition filing deadlines with user fee goals, agency could discourage petitions that need response within 150 days, potentially ending non-substantive response practice.

You may also be interested in...



International Pricing Index Could Suffer From Industry Gaming

Former US FDA commissioner Scott Gottlieb doesn't "want to give too much away," but expresses skepticism about Trump administration's ability to implement its international price index proposal, noting there are ways for brand companies to game the system.

To Lower Drug Prices, Look At Generic Industry Health Rather Than FDA, Woodcock Says

US FDA can encourage and increase competition, but cannot force generic companies to enter markets deemed unprofitable, CDER director says.

Citizen Petitions Targeting ANDAs Recede, But Concerns Over Resources Remain

FDA worries about diverting resources to respond to 505(q) petitions, despite receiving lowest number in fiscal year 2015 since it began tracking requests.

Related Content

Topics

UsernamePublicRestriction

Register

PS123997

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel